USP 797 Guidelines & Standards

Beyond-use dates for CSPs are rarely based on preparation-specific chemical assay results, which are used with the Arrhenius equation to determine expiration dates see General Notices and Requirements for manufactured products. The majority of CSPs are aqueous solutions in which hydrolysis of dissolved ingredients is the most common chemical degradation reaction. The extent of hydrolysis and other heat-catalyzed degradation reactions at any particular time point in the life of a CSP represents the thermodynamic sum of exposure temperatures and durations. Such lifetime stability exposure is represented in the mean kinetic temperature calculation see Pharmaceutical Calculations in Prescription Compounding Drug hydrolysis rates increase exponentially with arithmetic temperature increase; thus, exposure of a beta-lactam antibiotic solution for one day at controlled room temperature see General Notices and Requirements will have an equivalent effect on the extent of hydrolysis of approximately 3 to 5 days in cold temperatures see General Notices and Requirements. Personnel who prepare, dispense, and administer CSPs must store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs. When CSPs are known to have been exposed to temperatures warmer than the warmest labeled limit, but not exceeding 40 see General Notices and Requirements for more than 4 hours, such CSPs should be discarded, unless appropriate documentation or direct assay data confirms their continued stability. Determining Beyond-Use Dates. When CSPs deviate from conditions in the approved labeling of manufactured products contained in CSPs, compounding personnel may consult the manufacturer of particular products for advice on assigning beyond-use dates based on chemical and physical stability parameters.

USP panel sends revised compounding standards back for expert review

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The only exception is if you have a USP The beyond use date for an opened or entered (e.g. Maintain separately from patient chart.

A beyond-use date is a date placed on a prescription by a pharmacy for compounded medications they prepare, noting when that prescription should no longer be used. This date is determined by the pharmacy when they prepare a compound prescription based on different factors, including:. The beyond-use date is different than an expiration date of a drug. This includes moving a medication to a different container, which is the normal practice for pharmacies dispensing prescriptions.

Based on the type of drug, how fast it degrades, dosage, type of container, storage conditions, prescription length, the likelihood of contamination. Based on testing a drug in specific conditions related to storage containers, lighting, temperature, etc. The FDA says it’s dangerous to take medications after their expiration date because they may not be as effective, their chemical composition may have changed, or they may have deteriorated to a point where harmful bacteria could breed.

Particularly with antibiotics, it’s important to watch the expiration date because using an expired antibiotic means it may not be potent enough to completely treat your infection, leaving you at risk for a worse one. The bottom line is that it is best to not use expired medications because there is no guarantee that they will work the way they are supposed to and they may even make you worse.

Medications need to be stored safely to help keep their chemical compositions intact and stop them from becoming breeding grounds for bacteria. Storing them properly until they are expired keeps them safe and at maximum potency. Dealing with racing thoughts?

Beyond Use Date Chart – 797 Beyond Use Dating Chart Regulating Compounding Pharmacies

Gloved Fingertip Sampling Bacteria. Sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. USP provides guidelines, procedures and compliance requirements for compounding sterile preparations. USP describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

The standards in this chapter are intended to apply to all persons who prepare compounded sterile preparations CSPs and all places where CSPs are prepared e.

At each step of the compounding process, the pharmacist shall ensure that USP Chapter , USP Chapter , Pharmaceutical Compounding–Sterile (B​) require the practitioner or receiving pharmacy to include on a patient’s chart.

This chapter provides procedures and requirements for compounding sterile preparations. Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices.

Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients. The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination nonsterility , excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.

The quality control and testing for CSPs in this chapter are appropriate and necessary. The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed. For the purposes of this chapter, CSPs include any of the following:. Preparations prepared according to the manufacturer’s labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination.

Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration.

Summary of USP 797 for Compounding Sterile Preparations

However, the following provides a synopsis to clarify revision content breakdown:. The purpose of U. Pharmacopeia USP is to provide the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre-administration phase of sterile preparations. It describes the CSP requirements guidelines, USP procedures and compliance for CSPs and sets the standards that apply to all settings in which sterile preparations are compounded.

Adherence to will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors. The standard applies to anyone who prepares CSPs and all places where they are prepared.

Sterile compounding differs from nonsterile compounding (see Predictions based on other evidence, such as publications, charts, and tables, would result in within USP , for developing and implementing appropriate procedures, and.

The proposed chapter was open to public comments until November 30, , and is expected to become official on December 1, The proposed revision differs from the current chapter in both its structure and its content. Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate. Here is a summary of some of the changes.

The current chapter classifies compounded sterile preparations CSPs as low-, medium-, or high-risk level CSPs based on the sterility of the starting components and the number and types of compounding manipulations. The proposed chapter, however, eliminates this system of classifications and instead classifies sterile preparations as either a category 1 or category 2 CSP based on the conditions under which the product was prepared. The proposed chapter also changes the system for assigning beyond-use dates to CSPs.

Usp 797 beyond use dating chart

Designing a Verification and Monitoring Program. Designing a CSP Facility. Designing a Quality Management System. Teaching Adult Learners.

Overview of USP Compounding Chapter Revisions – Elaine Strauss. • Project Overview USP Pharmaceutical Compounding Sterile Preparations. • USP Optimal Concept Pharmacy Diagram. Gen. Pharmacy.

Contaminated CSPs are potentially most hazardous to patients when administered into body cavities, central nervous and vascular systems, eyes, and joints, and when used as baths for live organs and tissues. When CSPs contain excessive bacterial endotoxins see Bacterial Endotoxins Test 85 , they are potentially most hazardous to patients when administered into the central nervous system. Despite the extensive attention in this chapter to the provision, maintenance, and evaluation of air quality, the avoidance of direct or physical contact contamination is paramount.

It is generally acknowledged that direct or physical contact of critical sites of CSPs with contaminants, especially microbial sources, poses the greatest probability of risk to patients. Therefore, compounding personnel must be meticulously conscientious in precluding contact contamination of CSPs both within and outside ISO Class 5 see Table 1 areas.

To achieve the above five conditions and practices, this chapter provides minimum practice and quality standards for CSPs of drugs and nutrients based on current scientific information and best sterile compounding practices. The use of technologies, techniques, materials, and procedures other than those described in this chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein.

The standards in this chapter do not pertain to the clinical administration of CSPs to patients via application, implantation, infusion, inhalation, injection, insertion, instillation, and irrigation, which are the routes of administration.

Current Developments

Compounding has been a fundamental aspect of providing medicines to patients for centuries. Physicians, chemists, and pharmacists manipulated naturally derived products including those of plant, mineral, and animal origin into medicines. They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills.

Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines. Sterile preparations typically include injections, infusions, and some irrigation, ophthalmic, and inhalation preparations.

The proposed revisions address the subject of pharmaceutical compounding. and sterile compounding consistent with USP Chapters and the direct supervision of registered pharmacy interns, who may assist in chart reviews.

Note: certain features of this site have been disabled for the general public to prevent digital piracy. You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website. You agree that you will not sell or license anything that you download, print, or copy from this website. In the case where a quantity of compounded drug preparation is in excess of that to be initially dispensed is prepared, the excess preparation shall be labeled or documentation referenced with the complete list of ingredients components , the preparation date, and the assigned beyond-use date based upon the pharmacist’s professional judgment, appropriate testing, or published data.

It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics e. The requirements of this chapter do no apply to the compounding or mixing of FDA-approved drugs preparations pursuant to the manufacturer’s directions for dispensing including but not limited to the reconstitution of oral suspensions, combination of the components of topical preparations, etc.

R oute : S earch tips. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns. Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling.

Known allergies; 2.

Aseptic Technique Part 1

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